Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

Key Inclusion Criteria:

- Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of
the stomach or GEJ which have progressed on at least 1 prior systemic therapy or line
of treatment for unresectable/metastatic disease

- Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 1

- Measurable disease according to RECIST v1.1

- Tumor sites that can be accessed for repeat biopsies

- Archival tumor tissue, preferably obtained from the most recent available biopsy;
there must be adequate tissue for a PD-L1 stratification test, as assessed by central
pathologist

- Individuals not receiving anticoagulant medication must have an international
normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin (aPTT) ≤ 1.5 x upper
limit of normal (ULN)

- Required baseline laboratory data as outlined in protocol

Key Exclusion Criteria:

- Individuals who have received only neoadjuvant or adjuvant therapy for gastric
adenocarcinoma

- Radiotherapy within 28 days of randomization

- Uncontrolled intercurrent illness as outlined in protocol

- History of a concurrent or second malignancy except for those outlined in protocol

- Major surgery, within 28 days of first dose of study drug

- Known positive status for human immunodeficiency virus (HIV)

- Known acute or chronic-active infection with hepatitis B virus (HBV) or hepatitis C
virus (HCV)

- Chronic daily treatment with oral corticosteroids (dose of > 10 mg/day prednisone
equivalent) or other immunosuppressive medications within 14 days of randomization

- Known or suspected central nervous system metastases

- Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6
months of randomization

- Serious systemic fungal, bacterial, viral, or other infection that is not controlled
or requires intravenous antibiotics

- Current or history of pneumonitis or interstitial lung disease

- Active known or suspected autoimmune disease with exceptions noted in protocol.

- History of bone marrow, stem cell, or allogenic organ transplantation

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.